Objectives: The current study will aim to compare abdominal lavage with normal saline and normal saline plus antibiotic (gentamicin) in secondary peritonitis.
Design: This is a triple-blind, randomized clinical trial.
Setting and conduct: This study will perform at the Baqiyatallah University of Medical Sciences. In this study, the patients, measuring the outcomes of study participants (researchers) or Data Monitoring Committee (analyzers) of the patients unaware about intervention.
Patients in both groups will divide randomly using a table of random numbers. Count of Bacteria is another outcome in this study and assess using the laboratory. This clinical trial is a phase 3 study.
Major Inclusion and Exclusion criteria: Inclusion criteria: patients with the diagnosis of secondary peritonitis that have age between 15 to 60 years will undergo for urgent laparotomy were included.
Exclusion Criteria: A history of allergy to gentamicin, normal saline; history of kidney disease, dialysis, hemodialysis, uncontrolled hypertension; evidence of infection at or adjacent to the operative site; and the perceived inability to follow the patient’s course postoperative; patients with peritoneal carcinomatosis.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016092529818N1
Registration date:2016-10-30, 1395/08/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-10-30, 1395/08/09
Registrant information
Name
Shahram Manoochehry
Name of organization / entity
Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8805 3766
Email address
shahram.manoochehry@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Baqiyatallah University of Medical Sciences
Expected recruitment start date
2016-02-20, 1394/12/01
Expected recruitment end date
2016-10-22, 1395/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trials of normal saline with normal saline plus antibiotic in abdominal lavage in secondary peritonitis
Public title
Comparison of normal saline with normal saline plus antibiotic in abdominal lavage in secondary peritonitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with the diagnosis of secondary peritonitis that have age between 15 to 60 years will undergo for urgent laparotomy were included.
Exclusion criteria: A history of allergy to gentamicin, normal saline; history of kidney disease, dialysis, hemodialysis, uncontrolled hypertension; evidence of infection at or adjacent to the operative site; and the perceived inability to follow the patient’s course postoperative; patients with peritoneal carcinomatosis.
Age
From 15 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Baqiyatallah University of Medical Sciences
Street address
Postal code: 1435917541, Mollasadra, St - Sheikh Bahaee, St, Tehran
City
Tehran
Postal code
1435917541
Approval date
2015-09-23, 1394/07/01
Ethics committee reference number
IR.BMSU.REC.1394.171
Health conditions studied
1
Description of health condition studied
peritonitis
ICD-10 code
K65.0
ICD-10 code description
Acute peritonitis
Primary outcomes
1
Description
Infection
Timepoint
One and two weeks after operation
Method of measurement
Medical evaluation
Secondary outcomes
1
Description
Recurrence
Timepoint
One and two weeks after operation
Method of measurement
Medical evaluation
Intervention groups
1
Description
Intervention 1: normal saline and antibiotics gentamicin, gentamicin 240 mg per 500 mL of saline once during surgery. Normal saline containing 9.0 g of salt per liter (0.90%) and gentamicin formula is C21H43N5O7. How to use: At the end of surgery, a stomach lavage with antibiotic gentamicin 240 mg per 500 ml of normal saline will be given 5 minutes later, the solution is removed from the patient's abdomen. Brand of Saline and gentamicin are Saline and gentamicin.
Category
Treatment - Drugs
2
Description
Intervention 2: normal saline, per 500 mL of saline once during surgery. Normal saline containing 9.0 g of salt per liter (0.90%). How to use: At the end of surgery, a stomach lavage with antibiotic gentamicin per 500 ml of normal saline will be given 5 minutes later, the solution is removed from the patient's abdomen. Brand of Saline is Saline.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Surgery Department of Baqiyatallah hospital
Full name of responsible person
Sahram Manoochehry
Street address
Postal code: 1435917541, Mollasadra Street, Sheikh Bahaee St, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Baqiyatallah University of Medical Sciences
Full name of responsible person
Hamid Reza Rasouli
Street address
Postal code: 1435917541, Mollasadra Street, Sheikh Bahaee Street, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Baqiyatallah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Baqiyatallah University of Medical Sciences
Full name of responsible person
Shahram Manoochehry
Position
Faculty member/General surgery
Other areas of specialty/work
Street address
Postal code: 1435917541, Mollasadra Street, Sheikh Bahaee Street, Tehran
City
Tehran
Postal code
1435917541
Phone
+98 21 8805 3766
Fax
Email
shahram.manoochehry@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Baqiyatallah University of Medical Sciences
Full name of responsible person
Shahram Manoochehry
Position
Faculty member/General surgery
Other areas of specialty/work
Street address
Postal code: 1435917541, Mollasadra Street, Sheikh Bahaee Street, Tehran
City
Tehran
Postal code
1435917541
Phone
+98 21 8805 3766
Fax
Email
shahram.manoochehry@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Baqiyatallah University of Medical Sciences
Full name of responsible person
Sahahram Manoochehry
Position
Faculty member/General surgery
Other areas of specialty/work
Street address
Postal code: 1435917541, Mollasadra Street, Sheikh Bahaee Street, Tehran
City
Tehran
Postal code
1435917541
Phone
+98 21 8805 3766
Fax
Email
shahram.manoochehry@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)